Search Results

HALYARD ONE-STEP and QUICK CHECK Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using the Stryker Sterizone VP4 Sterilizer Cycle 1.

The HALYARD ONE-STEP and QUICK CHECK Sterilization Wraps are intended to allow sterilization of the enclosed devices by the Stryker Sterizone VP4 Sterilizer Cycle 1. All models of the Halyard ONE-STEP and QUICK CHECK Sterilization Wrap have been validated for use with the Stryker Sterilizer Cycle 1 as described below:

Halyard Sterilization Wrap is supplied to the customer as bulk packages of single sheets, where in accordance with standard hospital practices, two sheets are then used to wrap a medical device or a collection of medical devices for sterilization. HALYARD ONE-STEP and HALYARD QUICK CHECK Sterilization Wraps are comprised of two sheets of HALYARD* Sequential Sterilization Wrap ultrasonically seamed on two edges. This allows for convenient wrapping with two sheets simultaneously.

Sterilization wrap is a square or rectangular sheet made of three-layer SMS (spunbond-meltblown-spunbond) polypropylene fabric treated with an antistatic treatment. The wrap allows a sterilized package to be opened aseptically.

The HALYARD ONE-STEP and QUICK CHECK Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using the Stryker Sterizone VP4 Sterilizer Cycle 1 which is a dual-sterilant, low temperature sterilizer that uses vaporized hydrogen peroxide (H2O2) and ozone (O3) in a single cycle. All models of the Halyard ONE-STEP and QUICK CHECK Sterilization Wrap have been validated for use with the Stryker Sterizone VP4 Sterilizer Cycle 1 as described below.

The document describes the acceptance criteria and performance of the HALYARD ONE-STEP and QUICK CHECK Sterilization Wraps. Since this device is a sterilization wrap, the criteria and studies are related to its ability to allow sterilization and maintain sterility, rather than AI/machine learning performance.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document provides details on the "Validation Loads" used, which can be considered the test sets for sterility:

• General instruments:
  • Load consisted of three (3) trays each containing three (3) lb of general medical instruments.
  • Load #7A consisted of three (3) trays each containing 25 lb of general medical instruments, for a total of 75 lb per load (excluding the loading rack).
• Rigid channel instruments:
  • Load #4A consisted of 15 lumens from rigid and semi-rigid channeled devices.
• Single and double channel flexible endoscopes:
  • Load #8A consisted of five (5) lumens from single and double channel flexible endoscopes.
• Multi-channel flexible endoscopes:
  • Load #9A consisted of one (1) multichannel flexible endoscope with four (4) channels.

The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given the nature of sterilization validation studies, they are typically prospective experimental tests conducted in a laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The "ground truth" here is the achievement of sterility, which is determined by standard microbiological testing methods (e.g., biological indicators, sterility assurance level) rather than expert consensus on images or clinical cases.

4. Adjudication method for the test set

Not applicable. The evaluation criteria are objective and measured through laboratory testing as described above, not through human adjudication of qualitative data.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a sterilization wrap, not an AI or imaging diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical product (sterilization wrap) and does not involve an algorithm.

7. The type of ground truth used

The ground truth used for performance evaluation is based on objective laboratory measurements related to sterility, physical properties, and biocompatibility. Specifically:

• Sterility Assurance Level (SAL) of 10-6 (microbiological testing).
• Compliance with specific physical properties standards (e.g., tensile strength, burst strength).
• Maintenance of sterility for a defined period (12 months).
• Biocompatibility criteria (non-cytotoxic, non-irritating, H2O2 residuals).

8. The sample size for the training set

Not applicable. This device is a physical product and does not involve AI or machine learning models that require a "training set."

9. How the ground truth for the training set was established

Not applicable for the same reason as point 8.

Ask a specific question about this device